Code of ethics in the use of Artificial Intelligence

Post published:January 27, 2024

At PVpharm, we aim to work with pharmaceutical, biotech, and MedTech companies, providing new ideas and making solutions that make health better for everyone. We believe that Artificial Intelligence (AI) can really change the way we do pharmacovigilance, improving our work every day. The large revolution in the implementation of tools that use AI in the day-to-day work of pharmacovigilance is undeniable, but we must keep a critical and analytical eye. That is why at PVpharm we have created a code of ethics for the use of AI to establish guidelines to be followed to ensure a safe, legal, and…

Online EVWeb training 29 January-2 February 2024

Post published:January 26, 2024

José Ortiz, CEO of PVpharm will be participating as a trainer, in the next EVWeb training on 29 Janyary 2 February 2024. The training will be delivered online in the morning time (9:00-13:30 CET). The training is targeted to: -Users who have to report and analyse suspected adverse reactions in the pre- and post-authorisation phase using the ISO/ICH E2B(R3) ICSR format-Users of EudraVigilance – new users and users already trained on working with EudraVigilance-Professionals performing electronic transmission of ICSRs, who operate as Gateway traders or as WebTrader (i.e., who use EVWEB or EV Post)-Sponsors of Clinical Trials-National Competent Authorities or…

Online XEVMPD training 21-23 February 2024

Post published:January 22, 2024

José Alberto Ayala Ortiz, CEO of PVpharm, will be participating as trainer in the next XEVMPD training on 21-23 February 2024. The training will be delivered online in the morning time (09:00-13:00 CET). The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products. Please…

Lecturer at the International Pharma Industry Congress – LATAM 2023

Post published:December 8, 2023

José Ortiz will be one of the speakers at the International Pharmaceutical Industry Congress - Latin America 2021. This is the most important event of the Pharmaceutical Industry in the region.

Defafios actuais de Farmacovigilancia

Post published:November 27, 2023

José Alberto Ayala Ortiz, CEO of PVpharm participated in the 1st edition of the Conference organized by OWL Pharma, Desafios Actuais de Farmacovigilancia, held in Lisbon on the 22nd of November 2023. José provided insight about Signal Detection in Pharmacovigilance and the use of EVDAS. Please check OWL Pharma website for more information: https://www.owlpharma.pt/news/o-futuro-de-farmacovigilancia-1a-edicao-desafios-atuais-de-farmacovigilancia **PVpharm is also organizing in-house training in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.**

Online XEVMPD training 27-29 November 2023

Post published:November 24, 2023

José Alberto Ayala Ortiz, CEO of PVpharm, will be participating as trainer in the next XEVMPD training on 21-23 February 2024. The training will be delivered online in the morning time (09:00-13:00 CET). The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products. Please…

Online EVWeb training for SPONSORS 27-29 November 2023

Post published:November 23, 2023

José Ortiz, CEO of PVpharm will be participating as a trainer, in the next EVWeb training specifically targeted for SPONSORs of Clinical trials on 27-29 November 2023. The training will be delivered online in the morning time (9:00-13:00 CET). The training is targeted to: -Sponsors who have to report and analyse suspected adverse reactions in the pre- authorisation phase using the ISO/ICH E2B(R3) ICSR format-Users of EudraVigilance – new users and users already trained on working with EudraVigilance-Professionals performing electronic transmission of ICSRs, who operate as Gateway traders or as WebTrader (i.e., who use EVWEB or EV Post)-Sponsors of Clinical…

José Alberto Ayala Ortiz to participate as speaker in the AEFI Pharmacovigilance in Social Networks Training

Post published:November 2, 2023

We are happy to announce that José Alberto Ayala Ortiz, PVpharm's CEO will be participating as speaker in the AEFI Pharmacovigilance in Social Networks Training. The training will take place on Monday 6th November from 16:00 to 19:00, please find more information about the training in the link below: https://aefi.org/eventos/farmacovigilancia-en-la-era-digital/?mc_cid=ddb97c2046&mc_eid=54a2a50032 During the session, José will be talking about several topics related to Pharmacovigilance and handling of safety related information detected in Social Networks.

DIA Pharmacovigilance System Master File (PSMF) and Global PSMF virtual courses (30 October and 2-3 November 2023)

Post published:October 30, 2023

José Ortiz will be participating as a trainer together with Marcela Fialova in the Pharmacovigilance System Master File (PSMF) and Global PSMF courses organized by DIA. The training will be delivered online from 13:00 PM to 17:00 PM (CET) on October 30 and November 2 to 3, 2023. These virtual live training courses covers essential concepts and guidance about the Pharmacovigilance System Master File (PSMF) and the PSMF from a global context. This key document describes the company’s pharmacovigilance system, supporting, and documenting its compliance with the requirements laid down in the EU legislation and is the first document requested…

Creación del Aula de Farmacovigilancia PVpharm – UGR

Post published:October 26, 2023

El martes 24-10-2023 tuvo lugar en el Rectorado de la Universidad, la firma Aula de Farmacovigilancia UGR & PVPharm, un espacio dedicado a incrementar el conocimiento y aprendizaje sobre Farmacovigilancia y la Industria Farmacéutica. Al acto de firma acudieron entre otros el Sr. Rector Magnífico de la Universidad, D. Pedro Mercado Pacheco, el CEO y fundador de PVPharm, D. José Alberto Ayala Ortiz, y el Sr. Decano de la Facultad,. D. Manuel Sánchez Polo. https://youtu.be/oJh6yrA3l5M El objetivo general de la presente colaboración entre PVpharm y la UGR es apoyar la realización de actividades de formación y difusión en el ámbito de la…